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The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal procedures. The compatible Dragonfly™ imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS imaging system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

OPTISTM with AptiVueTM Software (version E.5) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. FFR, Pd/Pa at rest, and RFR physiological waveforms measured by the system are used to assess the severity of a coronary lesion by measuring the pressure drop across the lesion (distal vs proximal pressure).

Here's an analysis of the acceptance criteria and study information for the ILUMIEN OPTIS with AptiVue Software version E.5, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the validation of the Resting Full-cycle Ratio (RFR) feature, comparing its diagnostic performance against Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR). The acceptance criteria are implicitly defined by achieving comparable diagnostic accuracy and agreement metrics.

2. Sample Size and Data Provenance:

The document does not explicitly state the exact sample size for the test set. However, it refers to a "prospective study... of RFR for the physiological assessment of coronary artery disease in real-world patients." The confidence intervals provided in the table, such as "91.1%, 95.6%" for diagnostic accuracy, indicate a substantial number of cases. Given the context of a 510(k) summary, specific details on country of origin are typically not provided, but the language suggests a clinical trial setting. The study was prospective.

3. Number of Experts and Qualifications:

The document does not specify the number of experts used to establish the ground truth for the test set, nor their qualifications.

4. Adjudication Method:

The document does not explicitly describe an adjudication method for the test set. It outlines a "RFR-FFR Hybrid Method Result Interpretation" which includes a grey zone where the decision would be "based on FFR." This implies FFR serves as the primary ground truth, and the RFR values are being compared against it.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. The document focuses on the performance of the RFR algorithm itself compared to established physiological indices (FFR and iFR). There is no information provided regarding the effect size of human readers improving with AI assistance vs. without AI assistance.

6. Standalone Performance:

Yes, a standalone performance study was done. The "Summary of RFR Validation Study" directly compares the diagnostic accuracy and agreement metrics of the RFR algorithm (standalone, or hybrid with FFR for the grey zone) against FFR as the gold standard, and against iFR-FFR for equivalence.

7. Type of Ground Truth Used:

The ground truth used is primarily Fractional Flow Reserve (FFR). For the RFR-FFR hybrid method, when RFR falls within a defined grey zone (0.86 ≤ RFR ≤ 0.93), the decision is explicitly stated to be "based on FFR." Therefore, FFR serves as the reference standard for determining ischemia-causing lesions.

8. Sample Size for the Training Set:

The document does not provide information about the sample size for the training set used to develop the AptiVue Software.

9. How the Ground Truth for the Training Set was Established:

The document does not provide information on how the ground truth for the training set was established. It describes the validation study of the RFR feature, not the development process of the software.

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The QUANTIEN™ Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

The QUANTIEN measurement system is intended for use in the catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

The QUANTIENTTM Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWireTM guidewire and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Relevant display data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Resting Full-Cycle Ratio (RFR) index, Pd/Pa and data from ECG.

Information on the display screen may also be transferred to the cathlab monitoring system or an offsite video monitor. Recorded procedures can be viewed on a PC, with application specific viewing software installed such as RadiView, for post procedural review and analysis.

Quantien allows for importing of a patient work list from the hospital DICOM system, exporting of recorded measurement data to DICOM or to an external server location or portable (USB) memory device.

Here's a summary of the acceptance criteria and study details for the QUANTIEN™ Measurement System with Software Version 1.12.1. as presented in the provided document:

Acceptance Criteria and Device Performance

Note: The acceptance criteria are implicitly defined by demonstrating equivalence to the iFR-FFR hybrid approach, which itself serves as a benchmark for diagnostic utility in assessing coronary artery disease. The study aims to show that the RFR-FFR hybrid method performs comparably to the established iFR-FFR method.

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a numerical value for the overall study. However, the results are presented with 95% confidence intervals, which usually implies a sufficient sample size was used for statistical significance.
   • Data Provenance: Prospective study. The country of origin of the data is not specified in the provided document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not specify the number of experts or their qualifications used to establish the ground truth.
   • Instead, the "ground truth" for the comparison is RFR-FFR and iFR-FFR hybrid methods, where FFR is typically considered a reference standard in fractional flow reserve studies. The document does not describe an independent "expert consensus" or manual ground truth labeling for the images/data used. The comparison is between two algorithmic approaches.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not describe a specific adjudication method like 2+1 or 3+1. The study is a comparison of two physiological assessment methods (RFR-FFR vs. iFR-FFR), not a reader-based adjudication process for image interpretation.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done to evaluate human reader improvement with AI assistance. This study focuses on the comparison of two physiological indices (RFR and iFR) against FFR as the reference, not on human reader performance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance metrics (Diagnostic Accuracy, Agreement, PPV, NPV) presented for "RFR-FFR" and "iFR-FFR" represent the standalone performance of these hybrid methods. They involve algorithmic computation and interpretation based on defined thresholds (e.g., RFR < 0.86 for positive, FFR ≤ 0.8 for positive). There isn't a human-in-the-loop element described in these performance metrics.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" or reference standard used in this comparative study is Fractional Flow Reserve (FFR), which is a widely accepted physiological measure for assessing the hemodynamic significance of coronary artery stenoses. The study compares the RFR-FFR and iFR-FFR hybrid approaches against this standard.

7. The sample size for the training set:

   • The document states, "No new clinical testing was completed, nor relied upon, in support of this Traditional 510(k)." This implies that the RFR algorithm and its established thresholds were likely developed and validated prior to this submission, possibly through other studies. Therefore, the training set size is not provided in this document as it pertains to development data that was not newly generated for this submission.

8. How the ground truth for the training set was established:

   • Given the statement in point 7, the document does not describe how the ground truth for any training set was established for the RFR algorithm. The presented clinical testing is a validation study of the already established RFR method, not a development study.

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The Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The Advisor HD Grid Mapping Catheter, Sensor Enabled, is a sterile, singleuse, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an introducer tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is compatible with the EnSite Velocity and EnSite Precision Cardiac Mapping Systems and other accessories, including the connecting cable and commercially available irrigation pumps.

The provided text describes the St. Jude Medical Advisor HD Grid Mapping Catheter, Sensor Enabled. It mentions several types of testing conducted to demonstrate substantial equivalence to predicate devices, including bench, in vivo, and biocompatibility testing. However, the document does NOT contain a study that establishes acceptance criteria and provides specific device performance data in the format requested.

The document lists various performance characteristics that were tested (e.g., irrigation pressure, electrical resistance, magnetic resistance, and compliance to various ISO and ANSI/AAMI/IEC standards), as well as a "GLP safety study" and an "Accuracy study" as part of in vivo testing. It states that "The resulting evidence obtained from the design verification and validation testing did not raise new questions of safety and effectiveness, and demonstrates that the subject device is as safe and effective as the predicate devices."

However, it does not provide the acceptance criteria for these tests, nor does it present the reported device performance against those criteria in a quantitative manner. Therefore, I cannot complete the table or answer most of the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

Based on the provided text, I can only state that an "Accuracy study" was performed as an in vivo test, but no details about its methodology, results, or how it proved the device met specific acceptance criteria are given.

The information regarding acceptance criteria and a study proving their fulfillment is absent from the provided FDA 510(k) clearance letter and associated indications for use and device description.

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The EnSite Velocity Cardiac Mapping System is a suggested Diagnostic tool in patients for whom electrophysiology studies are indicated.
When used with EnSite Array Catheter, the EnSite Velocity Cardiac Mapping System is intended to be used in the right atrium of patients with complex arthythmias that may be difficult to identify using conventional mapping system alone.
Or
When used with the EnSite Velocity Surface Electrode Kit, the EnSite Velocity Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart

EnSite Precision Cardiac Mapping System v2.2:
The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
or
When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

EnSite™ Verismo™ Segmentation Tool: The EnSite Verismo™ Segmentation Tool is indicated for use in generating 3D models from CT, MR or rotational angiography DICOM image data. Generated models are intended to be displayed on the EnSite Velocity System.

EnSite™ Derexi™ Module: When used with EnSite Derexi ™ Module, the EnSite System interfaces to the EP-WorkMate™ System / WorkMate Claris™ System for synchronizing and display of patient information.

EnSite™ Courier™ Module: When used with EnSite Courier Module allows the patient data to be archived to, and retrieved from, a DICOM conformant PACs server.

EnSite™ Fusion™ Registration Module: EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.

EnSite™ Contact Force Module: When used with the SJM Contact Force Unit, the EnSite™ Contact Force Module is intended to provide visualization of force information from compatible catheters.

EnSite™ AutoMap Module: When used with the EnSite AutoMap Module, the EnSite System is intended to automatically collect mapping points based on criteria set by the user.

EnSite™ AutoMark Module: When used with compatible hardware, the AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.

The EnSite™ Velocity™ Cardiac Mapping System with software version 5.2 / EnSite Precision™ Cardiac Mapping System with software version 2.2 is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.

The EnSite™ Velocity™ Cardiac Mapping System is used as a diagnostic tool in electrophysiology (EP) Studies. An EP study involves the introduction of one or more electrode catheters into the heart to record its electrical activity. These catheters connect to the EnSite™ Velocity™ Cardiac Mapping System through specialized catheter input modules (CIMs). The EnSite™ Velocity™ Cardiac Mapping System v5.2 is designed for use in the EP laboratory in conjunction with other equipment.

The EnSite Velocity™ Cardiac Mapping System consists of hardware and software elements. The EnSite Velocity / EnSite Precision System consists of software, a display workstation (DWS) subsystem (DWS, Monitors, DWS Accessory Kit, and DWS Power Kit), and an amplifier subsystem (Amplifier and Amplifier Accessory Kit). The DWS houses the system software and connects all the components together. The amplifier contains electronic circuitry and firmware responsible for collecting and transmitting the electrical signal data of the patient to the DWS software. Its primary function is to collect and transmit via Ethernet the electrical data detected from the patient. The amplifier accepts signals from NavLink, ArrayLink, CathLink, ECG Cable, RecordConnect, and GenConnect, converts these signals to a digital format, and sends them to the workstation for processing. The NavLink connects surface electrodes and the system reference surface electrode to the Amplifier. The ArrayLink connects the EnSite Array Multielectrode Diagnostic Catheter to the Amplifier. It also has a connection for an auxiliary unipolar reference electrode. The CathLink connects the diagnostic catheters to the Amplifier. The GenConnect connects the ablation catheter and dispersive surface electrodes to the Amplifier. The RecordConnect allows simultaneous connection for catheters and surface ECG to a recording system and to the Amplifier. The ECG cable connects standard ECG electrodes to the Amplifier. The system operates using impedance only or impedance plus magnetics based upon its configuration. The EnSite™ Velocity™ Cardiac Mapping System base software only collects impedance data. Adding EnSite Precision™ software to the base software allows the system to receive both magnetic data from the MediGuide™ Technology System or the EnSite Precision™ Module hardware and impedance data when using magnetic sensor enabled tools. The EnSite Precision™ Module and EnSite Precision™ software (added to the base software) together make up the EnSite Precision™ Cardiac Mapping System. The EnSite Precision™ software interfaces to the MediGuide Technology System or the EnSite Precision™ M Module to collect magnetic position and orientation information. The EnSite Precision™ software uses the magnetic data for magnetic field scaling (NavX SE), shift detection (EnGuide Stability Monitor), and respiration gating. NavX SE field scaling adjusts the dimensions of the navigation field based on both the positon and orientation of magnetic sensors and the electrodes on Sensor Enabled™ (SE) tools, optimizing the appearance of the model. The system uses EnGuide Stability Monitor to notify the user of a potential shift based on a correlation of magnetic and impedance locations when using any Sensor Enabled catheter. The system uses respiration gating to compensate to the end-point of the respiration cycle using magnetic data to determine respiration phase. The EnSite Precision™ Module consists of hardware to support magnetic navigation. The hardware components consist of the EnSite Precision™ Link, EnSite Precision™ Field Frame, and EnSite Precision™ Patient Reference Sensors.

The EnSite™ Velocity™ Cardiac Mapping System v5.2 includes the following optional expansion software modules:

1. EnSite™ Verismo™ Segmentation Tool - an optional expansion module used in generating 3D models from CT, MR or rotational angiography DICOM image data and displaying images on the EnSite™ Velocity™ Cardiac Mapping System. The EnSite™ Verismo™ Segmentation Tool accepts DICOM images from CT and MRI scanners and converts the images into a 3D model of cardiac structures.
2. EnSite™ Derexi™ Module - an optional expansion module that that allows the EnSite Velocity System to interface with the WorkMate™ Recording System to support the exchange of mapping point data and patient setup information between the two systems.
3. EnSite™ Courier™ Module - The EnSite™ Courier™ Module is an optional expansion module that allows the EnSite™ Velocity™ Cardiac Mapping System to communicate with the hospital PACS (Picture Archiving and Communication System) server for the purposes of storing and retrieving patient data in DICOM format.
4. EnSite™ Fusion™ Registration Module - an optional expansion module that provides non-fluoroscopic navigation, mapping, and labeling on a Digital Image Fusion (DIF) model. The module is used with the EnSite™ NavX™ Navigation and Visualization Technology Surface Electrode Kit and CT or MR scans segmented into a compatible file format. 3D models created from digital images from CT and MRI data can be imported onto the EnSite™ Velocity™ System.
5. EnSite™ Contact Force Module - an optional expansion module that provides the display of information from the TactiSys Quartz System. The EnSite Velocity System's EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
6. EnSite™ AutoMap Module - an optional module that automatically collects mapping points based on criteria set by the user
7. AutoMark Module - module allows the user to set parameters and the software automatically displays the lesion marks on the EnSite Velocity model during RF ablation. The user set parameters is based on data from Ensite™ Contact Force Module, the Ampere Generator, and the WorkMate Claris™ System which is displayed on the AutoMark Module as lesion marks on the during RF ablation. The color, size, and ranges of the AutoMark are defined by the user.

This document describes the regulatory submission (K172396) for the EnSite™ Velocity™ Cardiac Mapping System v5.2 and EnSite Precision™ Cardiac Mapping System v2.2. The submission is a Traditional 510(k) and focuses on minor software updates and support for a new catheter. The key takeaway regarding acceptance criteria and study data is that this submission primarily relies on non-clinical software verification and validation, performance testing, and preclinical animal studies, rather than large-scale clinical trials involving human experts for ground truth establishment.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

The document states that "Design verification activities for functional testing were performed with their respective acceptance criteria to ensure that the software modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, specific numerical acceptance criteria and reported device performance values are not explicitly detailed in the provided text. The general statement indicates that all criteria were met.

The device is a "Programmable Diagnostic Computer" for cardiac mapping. The performance is assessed based on:

• Catheter compatibility
• Catheter impact
• Functional testing
• EnGuide stability
• System accuracy
• Effective installation and continued intended use of the software version
• Overall clinically acceptable performance (from preclinical animal studies)

Since the document does not provide a table with specific numerical acceptance criteria and performance metrics, it's not possible to create one. The general acceptance criterion is that the software updates and new catheter support do not adversely affect the safety or effectiveness and meet established performance specifications.

Study Details

Given the nature of this submission (minor software update to an existing device, supporting a new catheter), the studies are primarily non-clinical.

1. A table of acceptance criteria and the reported device performance:

   • As mentioned above, specific numerical acceptance criteria and performance data are not provided in this document. The submission states that all testing performed met the established performance specifications.

2. Sample sized used for the test set and the data provenance:

   • Test Set (Non-Clinical): The document refers to "software verification and validation," "performance testing on the bench," and "preclinical animal studies."
     • Software Verification/Validation & Performance Testing: The exact sample sizes (e.g., number of test cases, number of bench tests) are not specified.
     • Preclinical Animal Studies: The sample size (number of animals) is not specified.
   • Data Provenance: The studies were conducted as part of the regulatory submission process for St. Jude Medical (now Abbott). The location of the testing is not specified, but it would typically be conducted at the manufacturer's facilities or a contract research organization. The studies are prospective as they were conducted to support this specific regulatory submission for the updated device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For non-clinical software and performance testing, "ground truth" is typically established by comparing the device's output against known, pre-defined correct behaviors or physical measurements using validated reference standards. This does not involve "experts" in the sense of clinicians interpreting patient data.
   • For the preclinical animal studies, the "ground truth" would be established by the animal study protocols, surgical procedures, and direct physiological measurements, assessed by veterinary and scientific personnel involved in the study. The number and qualifications of such experts are not specified in the document. This is not a human-in-the-loop clinical study requiring expert readers for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Given that this is primarily non-clinical testing (software verification, bench testing, animal studies), traditional clinical adjudication methods (like 2+1 reader consensus for image interpretation) are not applicable and not mentioned. Results would be evaluated against engineering specifications and veterinary assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. The document describes updates to a cardiac mapping system, which is a diagnostic tool, but not an AI-assisted diagnostic imaging system in the sense that would typically require an MRMC study to show human reader improvement. The updates are to the system's core mapping and navigation capabilities, and its interoperability, not directly to an AI component for image interpretation requiring human reader evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The software updates and new catheter support were evaluated for their standalone performance (e.g., software verification, bench testing to ensure system accuracy and stability, and animal studies to confirm proper function). The "algorithm only" performance would be part of the "functional testing" and "system accuracy" mentioned. Specific standalone performance metrics or studies are not detailed beyond the general statements that testing met specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For software verification and bench testing: The ground truth is based on engineering specifications, expected software behavior, physical measurements from laboratory equipment, and established hardware/software interface standards.
   • For preclinical animal studies: Ground truth is established through direct physiological data collection, procedural observations, and possibly post-mortem analysis in the animal models, as per the study protocol.
   • There is no mention of "expert consensus," "pathology," or "outcomes data" from human subjects for establishing ground truth in this particular submission.

8. The sample size for the training set:

   • The document does not mention a training set in the context of machine learning or AI models. This submission is for updates to a pre-existing cardiac mapping system, not the initial development or a significant AI component that would require a distinct "training set." The testing described is verification and validation of software changes and new hardware compatibility.

9. How the ground truth for the training set was established:

   • Since no training set for a machine learning/AI model is mentioned, this question is not applicable to the information provided.

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The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.

The PressureWire™ X guidewire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire™ X guidewire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable or with a specific transmitter. Both PressureWire™ X guidewire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system. The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is transmitted to associated equipment for analysis, calculations, and display of physiological parameters or indices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).

The provided text describes the PressureWire™ X guidewire, a medical device used to direct catheters and measure physiological parameters like blood pressure and temperature. The submission is a Special 510(k), indicating a minor design modification to an already cleared device (K161171). As such, a detailed comparative effectiveness study with human readers or extensive clinical trials are not typically required for this type of submission. The focus is on demonstrating that the modified device remains substantially equivalent to the predicate device and that the modification does not raise new safety or effectiveness concerns.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a Special 510(k) like this, the "acceptance criteria" are primarily based on demonstrating that the modified device performs comparably to the predicate device and meets established performance standards for its type. The reported device performance centers on various bench tests.

Note: The text states "Tests were conducted to evaluate the following: ... Additionally, simulated-use testing was completed as part of design validation to demonstrate the subject device met user needs and the intended use. The following test was performed: Signal Drift." It implies all these items were successfully met to demonstrate safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of units for each test. The text outlines categories of tests (e.g., Tensile Strength, Torque Strength) and generally states "Performance bench testing was completed as part of design verification" and "simulated-use testing was completed as part of design validation." Typically, for bench testing, a statistically relevant number of samples would be tested to ensure reliability. However, this specific number is not disclosed in the summary.
• Data Provenance: The testing was "Performance bench testing" and "simulated-use testing." This indicates the data was generated in a controlled laboratory environment, not from human or animal subjects. Thus, there's no "country of origin of the data" in the typical sense, nor is it retrospective or prospective clinical data. It's pre-market engineering and product verification/validation data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Number of Experts: Not applicable or mentioned. The "ground truth" for bench testing is defined by engineering specifications, validated test methods, and industry standards (e.g., for tensile strength, torque strength).
• Qualifications of Experts: Not applicable. The tests are designed to objectively measure physical and electrical properties according to predefined methods and pass/fail criteria.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench tests typically involve objective measurements and comparisons against predetermined specifications rather than subjective expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers improve with AI vs without AI assistance

• MRMC Comparative Effectiveness Study: No. The device is a physical guidewire with measurement capabilities, not an AI-powered diagnostic imaging tool that assists human readers in interpreting medical cases. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable in the context of an "algorithm only" device. The PressureWire™ X is a hardware device with an integrated sensor. Its "standalone performance" is demonstrated through the various bench tests ensuring the physical and measurement properties meet specifications.

7. The type of ground truth used

• Type of Ground Truth: For the "test set" (bench and simulated-use testing), the ground truth is based on engineering specifications, established physical properties, and validated measurement techniques. For example, a tensile strength test would have a pre-defined acceptable range of force the wire must withstand, and the measured force is compared against that objective standard.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a physical hardware product. It does not employ machine learning or AI algorithms that require a "training set" of data in the conventional sense. The "training" for such devices involves design, prototyping, and iterative testing, not algorithmic data training.

9. How the ground truth for the training set was established

• How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" for an AI algorithm in this context. The "ground truth" during the device's development (design and iterative testing) would similarly be based on engineering principles, material science, and performance specifications derived from intended use and predicate device characteristics.

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The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arthythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The myMerlin™ mobile application Model APP1001 is an application for patients who are implanted with the Confirm Rx™ Insertable Cardiac Monitor (ICM) Model DM3500 (K163407). The mobile application is used by patients to initiate recording of the heart's electrical activity by the Confirm Rx™ ICM device, read the information about the heart's activity from the Confirm Rx™ ICM device, and send this information to a clinician for remote monitoring. The myMerlin™ mobile application Model APP1001 is to be installed on a patient's mobile device with the iOS operating system which meets the specified minimum criteria for compatibility with the myMerlin™ mobile application.

This is a response to the question regarding the acceptance criteria and study proving the device meets the criteria. Based on the provided FDA 510(k) summary for the myMerlin™ Mobile Application, Model APP1001, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or detailed performance metrics for the myMerlin™ Mobile Application, Model APP1001. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (myMerlin™ Mobile Application Model APP1000).

The "performance" is implicitly defined by the device fulfilling its intended functions, which are:

• Initiating recording of the heart's electrical activity by the Confirm Rx™ ICM device.
• Reading information about the heart's activity from the Confirm Rx™ ICM device.
• Sending this information to a clinician for remote monitoring.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state a "test set" in the context of clinical data or patient samples. The evaluation appears to be based on non-clinical testing, specifically verification and validation (V&V) activities and risk analysis (FMEA/FMECA) related to software functionality and safety. Therefore, information about data provenance (e.g., country of origin, retrospective/prospective) for a test set of patient data is not provided as it doesn't appear to be a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since the document describes non-clinical software V&V and risk analysis, there is no mention of "experts" establishing ground truth in the context of medical image interpretation or diagnosis. The "ground truth" for V&V would be the predefined functional and performance specifications.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a "test set" requiring adjudication in a clinical context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. The device is a mobile application for data transmission and initiation of recording, not a diagnostic algorithm requiring human interpretation of its output.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The evaluation described is essentially a standalone assessment of the software's functionality and safety (V&V, FMEA). However, it's not an "algorithm-only" performance in the sense of a diagnostic algorithm because its primary function is data acquisition and transmission, not independent diagnosis. Its performance is validated against its specifications for these functions.

7. Type of Ground Truth Used

For the non-clinical testing (verification and validation), the "ground truth" would be the predefined design specifications and functional requirements of the software, as well as established software engineering best practices and regulatory standards for medical device software. For the risk analysis (FMEA/FMECA), the ground truth is the identification of potential failure modes and their associated risks, evaluated against acceptable risk levels.

8. Sample Size for the Training Set

Not applicable. This device is a mobile application for data management and transmission, not an AI/ML algorithm that requires a "training set" of data for learning or pattern recognition.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned for this device.

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The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The St. Jude Medical Confirm Rx™ system consists of the following key features and components:

• Confirm RxTM ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It is predicated on SJM Confirm™ DM2102 with a two-year longevity, MR conditional labeling, and identical sensing and detection algorithms as SJM Confirm™ DM2102, but with downsized hardware and Bluetooth communication.
• Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool to implant the device subcutaneously.
• Model 3111 Magnet (existing SJM donut magnet) facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
• Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS Programmer 3650 operates using Merlin PCS Model 3330 software and provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration and trend information.
• myMerlin™ Patient App (Model APP1000 Android): The Patient App provides the means for the patient to activate EGM recording in the Confirm Rx™ device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network.
• Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net MN5000 system allows physicians to remotely monitor and diagnose patients' cardiac events.

The provided text describes the Confirm Rx™ Insertable Cardiac Monitor (ICM) System, Model DM3500.

Here's an analysis of the acceptance criteria and the studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the Confirm Rx™ ICM leverages the existing market-cleared SJM Confirm™ (DM2102) algorithms and functionality. Therefore, the "acceptance criteria" for the detection algorithms are implicitly inherited from the predicate device. While specific numerical targets for metrics like sensitivity or specificity are not explicitly stated as acceptance criteria for the Confirm Rx™ ICM in this summary, the key performance aspects verified through testing are:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. It typically does not contain the detailed clinical study reports or comprehensive performance metrics that would be found in a full PMA application or a detailed peer-reviewed publication. The "acceptance criteria" here are therefore inferred from the context of substantial equivalence to a previously cleared device.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document does not explicitly state a specific sample size for a clinical test set used to evaluate the Confirm Rx™ ICM's diagnostic performance for arrhythmia detection. It states: "R-wave detection and device migration were verified via bench and animal testing for the Confirm Rx™ ICM DM3500." and "The Confirm Rx™ ICM leverages the existing market cleared SJM Confirm™ (DM2102) algorithms and functionality for which the clinical testing, performed on the SJM Confirm™ (DM2102) device per St. Jude Medical IDE G080090, is applicable and was not repeated."
• Data Provenance: The document does not specify the country of origin for the data, but it refers to an IDE (Investigational Device Exemption) study (G080090) conducted for the predicate device, SJM Confirm™ (DM2102). IDE studies are typically prospective clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• This information is not provided in the 510(k) summary for the Confirm Rx™ ICM. Since the clinical performance data is leveraged from the predicate device, the details about ground truth establishment would reside in the original IDE G080090 submission for the SJM Confirm™ (DM2102).

4. Adjudication Method for the Test Set:

• This information is not provided in the 510(k) summary. Details on adjudication methods would typically be found in the full clinical study report for the predicate device (IDE G080090).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• No MRMC comparative effectiveness study is mentioned. The Confirm Rx™ ICM is an insertable cardiac monitor that automatically detects and records cardiac events. It is not an AI-assisted diagnostic tool designed to improve human reader performance in interpreting medical images or complex waveforms. Its primary function is automated detection and recording, with physician review of the recorded electrograms (EGMs).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, the document implies standalone performance evaluation of the detection algorithms. It states that the Confirm Rx™ ICM utilizes "identical sensing and detection algorithms as SJM Confirm™ DM2102." These algorithms are designed for automated triggering of EGM storage based on detected events like tachycardia, pauses, and atrial fibrillation. The verification of R-wave detection (a fundamental aspect of these algorithms) was performed via bench and animal testing, suggesting an evaluation of the algorithm's performance independent of a human in the loop for the core detection task. Physicians later review the automatically captured EGMs.

7. The Type of Ground Truth Used:

• For the R-wave detection and device migration verification in the Confirm Rx™ ICM, the ground truth would likely be based on direct physiological measurements from bench testing and animal studies (e.g., direct electrical signals or physical tracking of device position).
• For the leveraged clinical performance of the detection algorithms (from SJM Confirm™ DM2102 IDE G080090), the ground truth for arrhythmia detection would typically involve expert consensus of ECG/EGM interpretation by cardiologists or electrophysiologists, potentially corroborated with other clinical data or findings.

8. The Sample Size for the Training Set:

• The document does not specify a training set sample size. Given that the device leverages "identical sensing and detection algorithms" from a predicate device, the algorithms were likely developed and "trained" (or more accurately, designed and optimized) at an earlier stage with data that is not detailed in this 510(k) summary. This summary focuses on verifying the new device's implementation of those existing algorithms, not on new algorithm development.

9. How the Ground Truth for the Training Set Was Established:

• This information is not provided in the 510(k) summary. As mentioned, the algorithms are inherited from a predicate. Details on their initial development and the establishment of ground truth for any underlying "training" or optimization data would be found in the documentation for the predicate device (SJM Confirm™ DM2102).

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OUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

QUANTIEN Measurement System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

The QUANTIENT™ Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes, but is not limited to: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Pd/Pa, and data from ECG.

Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressure to aortic pressure, measured during hyperemia. It provides the maximal blood flow in the presence of a stenosis as a fraction of the achievable blood flow that would exist in the hypothetical situation that the stenosis was not present. The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated. This functionality is achieved when the QUANTIENT™ Measurement System is used in conjunction with the manufacturer's distal intracoronary pressure transducer and a proximal aortic pressure transducer.

Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressure measured at resting conditions. The physician may use Pd/Pa at rest, along with knowledge of patient history, medical expertise and clinical judgment to determine if additional measurement of FFR during hyperemia or therapeutic intervention is indicated.

Information on screen can also be transferred to an external hemodynamic recording system (HRS) or to an external video monitor. Recorded procedures can be viewed on a PC for post-procedural review and analysis with application specific viewing software installed, such as RadiView™ software.

Additional functions let you import a patient work list from the hospital DICOM system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick.

This document describes the QUANTIENT™ Measurement System, a diagnostic computer designed to record, compute, display, and store data from PressureWire™ guidewire and other external transducers for the diagnosis and treatment of coronary or peripheral artery disease.

This 510(k) pertains to a Special 510(k) submission, meaning it compares a modified version of a device to an already cleared predicate device (QUANTIENT™ Measurement System, K123984). The focus is on demonstrating substantial equivalence, meaning the modified device has the same intended use and technological characteristics as the predicate, and does not raise new questions of safety and effectiveness.

1. A table of acceptance criteria and the reported device performance

Since this is a Special 510(k) submission for a substantially equivalent device, the performance acceptance criteria are implicitly those established for the original predicate device (K123984). The document explicitly states: "The intended use and technological characteristics of the QUANTIENT™ Measurement System that is subject to this Special 510(k) submission are the same as the predicate."

Therefore, the reported device performance for the subject device (K172182) is considered to be equivalent to the predicate device. The document does not provide a specific table of numerical acceptance criteria or performance metrics for the K172182 device itself, as the basis of this submission is equivalence to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "No new non-clinical testing was completed, nor relied upon, in support of this Special 510(k) submission." and "No new clinical testing was completed in support of this Special 510(k) submission."

Therefore, no new test set was used for this particular submission. The data provenance and sample size would refer to the testing done for the predicate device (K123984), which is not detailed in this document.

The document does mention: "Physician use and data analysis was completed and published publicly. Comparison to FFR was equivalent clinically, and comparison to iFR (as per the guidelines) was shown equivalent in clinical literature and publication." This indicates that previous clinical data support the use of the technology, but specific details on sample size, design, and provenance related to these publications are not provided within this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable to this Special 510(k) submission as no new testing was performed and no new ground truth was established for the subject device (K172182). The ground truth would have been established during the development and clearance of the predicate device (K123984), but details are absent here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new test set was used for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a diagnostic computer for physiological parameters, not an AI-assisted diagnostic tool for image interpretation or similar. The document does not mention any MRMC studies or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone system that computes and displays physiological parameters. It is "algorithm only" in the sense that it performs calculations based on transducer outputs without requiring direct human interpretation of raw signals for its primary function. However, the output (FFR, Pd/Pa values) is intended to be used by a physician "along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated." Therefore, it's a standalone measurement device providing data for human interpretation, rather than an "algorithm only" diagnostic system making a definitive diagnosis without human oversight.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the predicate device, the ground truth for physiological parameters (like blood pressure, FFR, Pd/Pa) would typically be established through comparison to established reference standards, often involving direct physical measurements or highly accurate invasive measurement techniques during clinical studies. The document states "Comparison to FFR was equivalent clinically, and comparison to iFR (as per the guidelines) was shown equivalent in clinical literature and publication," implying that clinical outcomes and established clinical guidelines serve as the ultimate ground truth for the utility of these parameters. Specific details of the ground truth used for the predicate device's validation are not provided in this document.

8. The sample size for the training set

Not applicable. This is a Special 510(k) for a device that computes physiological parameters, not a machine learning or AI device that requires a distinct "training set" in the conventional sense. The device's algorithms are based on established physiological principles and measurement techniques, not on learning from a dataset.

9. How the ground truth for the training set was established

Not applicable, as there isn't a training set in the context of this device's functionality. The "ground truth" for the device's calculations refers to the accuracy of its physiological measurements against accepted standards.

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The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite™ Precision System interfaces to either the MediGuide™ Technology system or the EnSite Precision Module to combine and display magnetic processed patient positioning and navigation mapping information.

When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

OR

When used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

The EnSite Precision™ Cardiac Mapping System is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are based on the anatomy of the patient's own cardiac chamber.

The EnSite Precision™ Cardiac Mapping System with version 2.0 software is a new module that is designed to allow the system to interface to the EnSite Precision™ Module, Sensor Enabled, which is an alternative magnetic field-based medical positioning hardware kit for magnetic field scaling functionality.

This document does not contain the detailed acceptance criteria and study results in the format requested. While it outlines the device, its intended use, and that verification/validation activities were performed, it does not provide specific metrics or performance tables.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

• Missing. The document states "Design verification/validation activities were performed with their respective acceptance criteria to ensure that the modifications do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, it does not specify what those acceptance criteria were or what the measured performance results were against those criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Partially Missing. The document mentions "Dynamic Wetlab Bench Comparative and Preclinical Animal testing."
  • Sample Size: Not specified.
  • Data Provenance: "Wetlab Bench" and "Preclinical Animal testing" suggest laboratory/animal studies, which are prospective. Country of origin not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable / Missing. This device is a cardiac mapping system for electrophysiology studies. The "ground truth" in this context would likely be precise catheter location measurements, which are typically established through highly accurate measurement systems, not expert consensus in the same way an image diagnosis would be. The document describes "magnetic field-based catheter localization" and "impedance locations" as mechanisms for determining position, suggesting instrumental ground truth rather than expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable / Missing. As the ground truth is instrumental (catheter position) rather than interpretive (e.g., diagnosing an image), adjudication methods by human readers are not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This document describes a K160210 submission for a cardiac mapping system, focusing on its technical performance and equivalence to predicate devices, not on AI assistance for human readers in diagnostic interpretation. The testing involved comparisons of model rendering and catheter electrode localization between the subject and predicate devices, and workflow performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, implicitly. The testing described ("Electrical, Mechanical, Accuracy and Repeatability, Packaging, shelf life, Biocompatibility, Preclinical Animal Studies") focuses on the device's technical performance. The "accuracy testing for use with the magnetic field scaling feature" and comparisons of "model rendering and location of catheter electrodes" are examples of standalone performance evaluation of the system's ability to accurately map and localize.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth would be based on highly accurate physical measurements for catheter positions in the wetlab/animal studies. The document states "magnetic field-based catheter localization used for field scaling during model creation involves sensing of the magnetic fields generated through small coil sensors embedded inside the enabled device." This implies a physical, instrumental ground truth for position validation.

8. The sample size for the training set:

• Not Applicable / Missing. This document describes a device approval, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" here refers to the device's development and validation, which uses various engineering and animal studies.

9. How the ground truth for the training set was established:

• Not Applicable / Missing. See point 8. The ground truth for validation testing (such as catheter position) would be established through precise physical measurement techniques in the wetlab or animal models.

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The MediGuide™ Technology system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide Enabled™ (equipped with a magnetic sensor) invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated for use as an adjunct to fluoroscopy.

MediGuide Technology enables navigation of devices on pre-recorded X-ray images allowing the physician to reduce the duration of live X-ray during a procedure. MediGuide Technology applies 3D visualization and precise navigation to pre-recorded 2D X-ray images and can be used by the physician to perform complex electrophysiology procedures and CRT implants. MediGuide Technology is analogous to a global positioning system (GPS) in that it uses a low powered electromagnetic field to locate device-based sensors in three-dimensional space. The system uses this location information to overlay MediGuide™ Enabled/Sensor Enabled™ devices on the corresponding pre-recorded X-ray image, which allows the physician to reduce the duration of live X-ray during a procedure. MediGuide creates a real-time clinical environment by compensating for patient motion, respiration and heart rate variability

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. The document describes the "MediGuide Technology System (Version 17.0)" and its regulatory clearance (K162643) by the FDA. It outlines the device's intended use and briefly mentions non-clinical testing.

However, it does not include:

• A specific table of acceptance criteria and reported device performance.
• Details about sample sizes for a test set, data provenance, ground truth establishment, or sample size for a training set.
• Information on the number and qualifications of experts or the adjudication method used.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone (algorithm only) performance study.

The document primarily focuses on regulatory aspects, comparison to a predicate device, and compliance with standards, rather than the specifics of a clinical or technical performance study in the way implied by your request. The "Summary on Non-Clinical Testing" section notes that "design verification activities for functional testing were performed with their respective acceptance criteria to ensure that software modifications and hardware addition do not affect the safety or effectiveness of the device. All testing performed met the established performance specifications." However, it does not detail these acceptance criteria or the specific results.

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